NCT01371253

Brief Summary

On a yearly basis roughly 40.000 individuals aged 65+ contact the emergency departments in Denmark as a result of an accidental fall, and in about 30% of these cases hospitalization is required. The cost of these admissions vary according to the type of injury with hip fractures being the most expensive accident {{113 Chrischilles,E. 1994; }}. The total average cost of a severe hip fracture in the Danish healthcare system resulting in nursing home placement has been estimated to approximately 365.000 Danish Kroner (Dkk) per year {{288 Christensen,P.M. 2005;}}. In addition, about 20 % of the elderly individuals who sustain a hip fracture will die within 6 months {{200 Brot,C. 2006; }}. For the society the outcome of falling in the elderly population is therefore not only associated with severe human but also economical consequences. Hence, it is essential to refine, develop and think "out of the box" when future intervention programs are designed and employed in the elderly community. One such "out of the box" intervention could be balance training with a Nintendo Wii Fit board (Nintendo Wii, Nintendo Co Ltd, Minami-ku Kyoto, Japan). The Nintendo Wii Fit board is a new generation of computer game which uses 3D tracking of the participants' motion and gestures. This means that the user interacts in and controls elements of the 3D gaming world with their own body {{307 LaViola,J.J.,Jr 2008;}}. In the case of the Wii Fit board, it detects the body sway and center of pressure (COP) of the participant and displays it onto a TV screen in different balance sceneries. A virtual character on the TV then reacts according to the user's movement and gesture (ex. skiing down a ski slope passing thru gates). This enables the user to perform tasks that, they may not be able to execute safely or at all in real-world situations. Interestingly in this context a study by Sihvonen et al from 2004 showed a compliance of 97,5% using the same technique as the Wii Fit only in 2D and with a poor graphical display. Further, the Sihvonen-study showed that 2D "biofeedback" intervention of only 4 weeks proved successful in terms of improved postural balance, physical activity and life quality {{297 Sihvonen,S. 2004;}}. Finally, traditional methods when promoting physical activity in the elderly population has been limited by lack of motivation or poor compliance (REFS), which possibly has prevented the elderly from reaching a maximum rehabilitation potential(REFS). Furthermore, in the follow-up period after these traditional intervention studies, it has been documented how difficult it is for the elderly to sustain the same training volume on themselves (REFS). Virtual reality systems like the Nintendo Wii Fit have been developed specifically for rehabilitation of the upper- {{301 Kuttuva,M. 2006;300 Dvorkin,A.Y. 2006;}} and lower-extremities and gait training {{298 Deutsch,J.E. 2007;}}. Further virtual reality platforms have been use for rehabilitation and training of reaching movements {{302 Piron,L. 2001;}}, motor coordination {{303 Broeren,J. 2002;}}, hand strength and range of motion, speed of hand movement{{304 Jack,D. 2001;305 Merians,A.S. 2002;}}. But so far most of these systems have not become commercially available possible due to a very high cost {{294 Deutsch,J.E. 2008;}}. Moreover in some cases the virtual rehabilitation environment has to be constructed from scratch making the hole process and implication very complicated {{306 Weiss,P.L. 2004;}}. Thus, designing an intervention program that utilizes the low-cost ready-to-use Wii Fit platform could be a possible research direction to explore. At the moment few studies have been conducted using the Nintendo Wii console. Among the few some have investigated the energy expenditure in kids (11-17 years of age) playing Wii Sports (bowling, tennis and boxing) compared to sedentary xbox games and actual bowling, tennis and boxing {{ 295 Graves,L.E. 2008; 296 Graves,L. 2008; }} while others have explored the Nintendo Wii console for rehabilitation of an adolescent with cerebral palsy {{294 Deutsch,J.E. 2008; }}. To the authors knowledge no studies have investigated the effect of 10 weeks of Nintendo Wii Fit balance training in seniors (+65 years). The main purpose of the study is to investigate the hypothesis: That 10 weeks of Nintendo Wii Fit balance training in a group of seniors (+65 years of age) have a significant effect on postural balance and muscle strength.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

January 19, 2012

Status Verified

January 1, 2012

Enrollment Period

4 months

First QC Date

June 9, 2011

Last Update Submit

January 18, 2012

Conditions

Keywords

Nintendo wiipostural balancemuscle strengthelderly

Outcome Measures

Primary Outcomes (3)

  • Balance

    M-L sway velocity, A-P sway velocity and velocity moment on a Metitur, FI " Good Balance"

    Baseline=june; Endline=september

  • Muscle strength

    Maximum muscle strength (MVC) and rate of force development (RFD) bilateral assessed on a Newtest,FI legpress

    Baseline=june; Endline=september

  • Motivation

    At the end of the study 3 questions on the likert scale will be asked in order to evaluate the participants motivation for further nintendo wii training.

    Baseline=june; Endline=september

Secondary Outcomes (2)

  • Fear of falling

    Baseline=june; Endline=september

  • Timed up and go

    Baseline=june; Endline=september

Study Arms (2)

Nintendo Wii traning

EXPERIMENTAL

Balance training

Other: Nintendo wii balance training

EVA-soles

PLACEBO COMPARATOR
Other: EVA-soles

Interventions

Nintendo Wii traning
EVA-soles

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age above 65 years
  • No physical therapy during the previous month
  • capable of understanding instructions
  • not recovering from acute illness
  • minimal loss of visual acuity
  • Selfprecived balance (good, average, poor) = average or poor
  • No orthopaedic Surgery within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg Hospital

Aalborg, North Denmark, 9000, Denmark

Location

Related Publications (1)

  • Jorgensen MG, Laessoe U, Hendriksen C, Nielsen OB, Aagaard P. Efficacy of Nintendo Wii training on mechanical leg muscle function and postural balance in community-dwelling older adults: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2013 Jul;68(7):845-52. doi: 10.1093/gerona/gls222. Epub 2012 Oct 31.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cand. scient.,Ph.d. Student

Study Record Dates

First Submitted

June 9, 2011

First Posted

June 10, 2011

Study Start

June 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

January 19, 2012

Record last verified: 2012-01

Locations